Elosan Efficacy Study (EES)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Elosan Cabin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Informed Consent
- adults, age ≥ 18 years, male or female patients
- History of pain ≥ 6 months
- Suffering from chronic pain, either reumatic pain or pain caused by traumata
- Intensity of pain rated ≥ 50 mm on VAS pain
Exclusion Criteria:
- Untreated thyroid disease
- History of seizure disorder (epilepsy)
- History of or current psychosis
- Women who are pregnant, breast feeding or intending to become pregnant
- Patients who are currently participating in other studies or have participated in other studies within the last 30 days
- Patients who have expressed their intention, or are suspected of intending, to discontinue therapy or stop therapy before the end of trial
- Patients with an electric or electronic implant.
Sites / Locations
- Polymedes Pain Center
- Centro Ortho-Bio-Med
- Zentrum für Neurochirurgie Hirslanden Ostschweiz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Elosan Cabin
No Treatment
Arm Description
Treatment with Elosan cabin
Continuation of taking pain medication as prescribed before study start.
Outcomes
Primary Outcome Measures
Change of Pain Intensity is being assessed by Visual Analogue Scale (VAS).
Change of Pain Intensity is being assessed on a horizontal 100 mm VAS (Visual Analogue Scale) pain scale. The total range of this scale is 100 mm. Minimum score is 0 mm, Maximum score is 100 mm. The higher values represent a higher intensity of pain. The values at baseline will be compared to the values at Visit 8 and the mean of the differences will be compared between the 2 treatment arms.
Secondary Outcome Measures
Change in quality of life is being assessed by SF 12 Questionnaire (The 12-Item Short Form Health Survey)
The change in quality of life (as reported by SF 12 questionnaires) from baseline to end of treatment (Day 28) will be compared between the treatment groups. The impact of the changes in summary scores (NBS: Norm-Based-Scoring) of physical health (PCS) and mental health (MCS) will be assessed by a General Linear Model (GLM) using the treatment as fixed factors and the baseline PCS and MCS as covariates, respectively.
Pain medication / pain therapy and any changes thereof shall be recorded during the study.
The pain medication taken at baseline will be compared to the amount of pain medication taken at the end of treatment. Changes in pain medication will be qualified by the investigators as either being clinically relevant or not.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03823729
Brief Title
Elosan Efficacy Study (EES)
Official Title
A Randomized, Open, Comparative Clinical Investigation to Show the Efficacy of a Short Time, Whole Body, Electrostatic High Voltage Application for Relief of Chronic Pain. Included in Study Can be Persons Suffering From Chronic Pain as it is Often Case With Rheumatic Disease or Traumata
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elosan AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The "Elosan Cabin" is a closed, electrically insulated, biocompatible cabin for the short-term application of electrostatic high voltage in patients with chronic pain, especially those with rheumatic diseases. Patients assigned to the Elosan group (group A) will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions. Patients assigned to the control group (group B) will have no treatment except for the continuation of their prescribed pain medication and pain therapy.
Detailed Description
Included in the study can be all persons suffering from chronic pain, as it is often the case with rheumatic disease or traumata. The Elosan therapy to be investigated aims to treat chronic pain by applying an electrical charge to the body surface and by disruption of positive bio-feedback to restore physiological reflex relations between the periphery and the central regulation. The electric charge is created by a generator which can produce an electrostatic field. The electrical voltage is delivered to the hands via a metal handle in a closed cabin and is spread over the entire body surface.
A total number of 42 patients will be included into this trial in order to show a statistically significant reduction of pain compared to reduction of pain in the control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients assigned to the Elosan group (group A) will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions. Patients assigned to the control group (group B) will have no treatment except for the continuation of their prescribed pain medication and pain therapy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elosan Cabin
Arm Type
Experimental
Arm Description
Treatment with Elosan cabin
Arm Title
No Treatment
Arm Type
No Intervention
Arm Description
Continuation of taking pain medication as prescribed before study start.
Intervention Type
Device
Intervention Name(s)
Elosan Cabin
Intervention Description
The Elosan Cabin is a closed, electrically insulated, biocompatible cabin for the short-term application of electrostatic high voltage. Patients assigned to the Group A will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions.
Primary Outcome Measure Information:
Title
Change of Pain Intensity is being assessed by Visual Analogue Scale (VAS).
Description
Change of Pain Intensity is being assessed on a horizontal 100 mm VAS (Visual Analogue Scale) pain scale. The total range of this scale is 100 mm. Minimum score is 0 mm, Maximum score is 100 mm. The higher values represent a higher intensity of pain. The values at baseline will be compared to the values at Visit 8 and the mean of the differences will be compared between the 2 treatment arms.
Time Frame
Change from Baseline Intensity of pain at 4 weeks
Secondary Outcome Measure Information:
Title
Change in quality of life is being assessed by SF 12 Questionnaire (The 12-Item Short Form Health Survey)
Description
The change in quality of life (as reported by SF 12 questionnaires) from baseline to end of treatment (Day 28) will be compared between the treatment groups. The impact of the changes in summary scores (NBS: Norm-Based-Scoring) of physical health (PCS) and mental health (MCS) will be assessed by a General Linear Model (GLM) using the treatment as fixed factors and the baseline PCS and MCS as covariates, respectively.
Time Frame
Change from Baseline at 4 weeks
Title
Pain medication / pain therapy and any changes thereof shall be recorded during the study.
Description
The pain medication taken at baseline will be compared to the amount of pain medication taken at the end of treatment. Changes in pain medication will be qualified by the investigators as either being clinically relevant or not.
Time Frame
before and after 4 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed Consent
adults, age ≥ 18 years, male or female patients
History of pain ≥ 6 months
Suffering from chronic pain, either reumatic pain or pain caused by traumata
Intensity of pain rated ≥ 50 mm on VAS pain
Exclusion Criteria:
Untreated thyroid disease
History of seizure disorder (epilepsy)
History of or current psychosis
Women who are pregnant, breast feeding or intending to become pregnant
Patients who are currently participating in other studies or have participated in other studies within the last 30 days
Patients who have expressed their intention, or are suspected of intending, to discontinue therapy or stop therapy before the end of trial
Patients with an electric or electronic implant.
Facility Information:
Facility Name
Polymedes Pain Center
City
Bad Ragaz
State/Province
CH
ZIP/Postal Code
7310
Country
Switzerland
Facility Name
Centro Ortho-Bio-Med
City
Roveredo
State/Province
CH
ZIP/Postal Code
6535
Country
Switzerland
Facility Name
Zentrum für Neurochirurgie Hirslanden Ostschweiz
City
St.Gallen
State/Province
CH
ZIP/Postal Code
9016
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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Elosan Efficacy Study (EES)
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